(Terminated because preliminary data suggested no difference in the strategies.)

Sponsor:

University of Washington

ClinicalTrials.gov Identifier:

NCT00394706

First Posted: November 1, 2006

Last Update Posted: April 30, 2012

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The purpose of this study is to look at two different treatments during a cardiac arrest that occurs outside of the hospital and whether either or both treatments will increase the number of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping blood to the body.

Further study details as provided by Susanne May, University of Washington:

Primary Outcome Measures:

Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3). [ Time Frame: Hospital discharge or death prior to discharge ]

The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.

Secondary Outcome Measures:

Survival to Hospital Discharge [ Time Frame: Survival to hospital discharge or death before discharge ]

Analyze early. Upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.

Other: Analyze early

Upon EMS arrival at the scene of a non-traumatic cardiac arrest, an assessment of the cardiac rhythm is done to determine whether a defibrillatory shock is required.

4

Analyze late. Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.

Other: Analyze later

Upon EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is given prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.

Detailed Description:

The first treatment involves using a device called the Impedance Threshold Device (ITD). The ITD is a small hard plastic device about the size of a fist that is attached to the face mask or airway tube used during CPR (cardiopulmonary resuscitation). The ITD provides increased blood flow back to the heart during chest compressions until the heart starts beating on its own again.

The other treatment involves the amount of CPR given before the emergency medical services (EMS) providers first look at the heart rhythm to determine if a shock is needed. A person would receive either about 30 seconds of chest compressions or about 3 minutes of compressions before checking the heart rhythm. Giving some compressions before checking the heart rhythm increases the blood being circulated to the body. Researchers do not know how many compressions before the rhythm check are necessary to save more lives.

Depending on the circumstances of the cardiac arrest a person may receive only one of these treatments or both of these treatments. The purpose of the research study is to determine if more people live when either the real ITD is used or if additional CPR is given before looking at the heart rhythm the first time. This study is being conducted in 9 different areas throughout the United States and Canada by the Resuscitation Outcomes Consortium (ROC). About 15,000 patients will be enrolled in this research study.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

All persons of local age of consent or older who suffer non-traumatic cardiopulmonary arrest outside of the hospital in the study communities with defibrillation and/or delivery of chest compressions provided by emergency medical service (EMS) providers dispatched to the scene and do not meet any of the exclusion criteria.

Exclusion Criteria:

Common:

Do not attempt resuscitation (DNAR) orders

Blunt, penetrating, or burn-related injury

Patients with exsanguinations

Known prisoners

Known pregnancy

Non-ROC EMS agency/provider

For Analyzing Late versus Early

EMS-witnessed arrests

Non-EMS rhythm analysis (AED placed by police or lay responder is an exclusion but CPR by lay or other non-EMS responders is not)

For ITD:

Tracheostomy present

CPR performed with the mechanical compression "Autopulse" device.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394706